| (19) |
 |
|
(11) |
EP 0 592 397 B1 |
| (12) |
EUROPEAN PATENT SPECIFICATION |
| (45) |
Mention of the grant of the patent: |
|
21.05.1997 Bulletin 1997/21 |
| (22) |
Date of filing: 11.01.1991 |
|
| (51) |
International Patent Classification (IPC)6: A61M 16/04 |
| (86) |
International application number: |
|
PCT/DK9100/010 |
| (87) |
International publication number: |
|
WO 9110/464 (25.07.1991 Gazette 1991/17) |
|
| (54) |
A RESPIRATION CATHETER
RESPIRATIONSKATHETER
CATHETER RESPIRATOIRE
|
| (84) |
Designated Contracting States: |
|
DE ES FR GB IT |
| (30) |
Priority: |
12.01.1990 DK 89/90
|
| (43) |
Date of publication of application: |
|
20.04.1994 Bulletin 1994/16 |
| (73) |
Proprietor: LOMHOLT, Vagn Niels Finsen |
|
DK-3450 Allerod (DK) |
|
| (72) |
Inventor: |
|
- LOMHOLT, Vagn Niels Finsen
DK-3450 Allerod (DK)
|
| (74) |
Representative: Wittrup, Flemming et al |
|
c/o Hofman-Bang & Boutard, Lehmann & Ree A/S,
Hans Bekkevolds Allé 7 2900 Hellerup 2900 Hellerup (DK) |
| (56) |
References cited: :
DK-B- 111 149
|
US-A- 3 794 036
|
|
| |
|
|
|
|
| |
|
| Note: Within nine months from the publication of the mention of the grant of the European
patent, any person may give notice to the European Patent Office of opposition to
the European patent
granted. Notice of opposition shall be filed in a written reasoned statement. It shall
not be deemed to
have been filed until the opposition fee has been paid. (Art. 99(1) European Patent
Convention).
|
[0001] The invention concerns a respiration catheter of the type stated in the introductory
portion of claim 1. Such a respiration catheter is known from DK-C-111149.
[0002] Endotracheal tubes intended for insertion through the mouth, nose or implanted in
the neck (oro-naso and tracheostomy tubes) are usually provided with an inflatable
cuff for sealing against the tracheal wall. The efficiency of the sealing is determind
by the magnitude of the cuff pressure against the tracheal wall since the inflated
cuff does not seal off pressures exceeding the pressure of the cuff against the wall.
The air pressure in the cuff determines the pressure against the tracheal wall. The
pressure of the cuff against the tracheal wall can be controlled and regulated only
if the cuff has a sufficiently large diameter to make contact with the tracheal wall
without any stretching of the sheet material of the cuff, i.e. the cuff must be lying
folded on the tracheal wall. If this demand is met, the pressure in the cuff is identical
with its pressure on the wall.
[0003] If the pressure of the cuff against the tracheal wall is considerably higher than
30 cm H
2O, the blood supply to the mucosa is occluded, and this causes damage in the form
of superficial or deeper ulcerations after some time. This damage is prevented in
that the sealing cuff, lying folded on the wall, is kept inflated from an outer pressure
source with a constant, regulated pressure of 20 to 30 cm H
2O.
[0004] The sealing cuff has the additional function of preventing liquid (blood, saliva,
vomit) from flowing past the cuff down into the lungs. It has been found that this
function is accomplished when the pressure of the sealing cuff against the tracheal
wall is at least 20 to 30 cm H
2O.
[0005] Spontaneous changes in the diameter of the trachea, changes in the catheter position
and the diffusion of certain anaesthetic gases through the wall of the sealing cuff
may cause considerable changes in the pressure in the sealing cuff if the inflation
pressure is not controlled and regulated.
[0006] During artificial respiration the necessary pressure of the respiration air may often
exceed 20 to 30 cm H
2O, and the pressure in the sealing cuff is then too low to seal off the pressure of
the respiration air.
[0007] In order for the sealing cuff to be able to seal off high inflation pressures during
artificial respiration, the respiration catheter described in DK-C-111149 is equipped
with a two-way cut-off valve mounted on the air supply tube for the sealing cuff.
In this embodiment closing and opening of the valve are controlled by the pressure
changes in the external opening of the catheter tube which are produced during artifical
respiration. When the pressure in the catheter tube during inflation exceeds the constant,
regulated pressure of 20 to 30 cm H
2O, the cut-off valve closes so that the air in the sealing cuff cannot escape through
the air supply tube, and the pressure increase in the tracheal tube is transferred
to the sealing cuff, the air in the sealing cuff being compressed so that the sealing
cuff can seal off the pressure prevailing in the trachea. When, during expiration,
the pressure in the catheter tube decreases to 20 to 30 cm H
2O, the cut-off valve opens again, providing free connection between the source of
compressed air and the sealing cuff, which then remains inflated by the constant,
regulated pressure of 20 to 30 cm H
2O.
[0008] The respiration catheter according to DK-C-111149 which also forms the preamble of
Claim 1 has the closing valve arranged in a respiration air supply tube at the external
opening of the catheter. Due to the flow resistance between the two ends of the catheter
and the consequent difference in pressure, the valve closes prematurely during inflation
and opens prematurely during expiration. This entails that part of the air in the
sealing cuff escapes during the expiration phase so that, for a short moment, the
cuff cannot provide an efficient sealing of the trachea.
[0009] The object of the invention is to provide an embodiment of a respiration catheter
of the present type which prevents the said malfunction involving the risk of liquid
flowing past the sealing cuff down into the lungs.
[0010] This object is obtained in that the respiration catheter is constructed as stated
in the characterizing portion of claim 1 since, in this structure, a pressure drop
in the catheter tube cannot at any time cause premature opening of the closing valve
and, consequently, neither undesirable escape of air from and thereby defective sealing
capacity of the cuff.
[0011] An appropriate position of the cut-off valve is stated in claim 2, and claim 3 defines
constructive means for establishing the desired cooperation between air supply tube,
valve and sealing cuff.
[0012] When the respiration cathether is constructed as stated in claim 4, one of the two
supply tube parts of this structure may be used for sucking liquid which accumulates
above the sealing cuff.
[0013] Claim 5 defines a simple and inexpensive embodiment of the cut-off valve. When such
a valve is arranged on the outer side of the catheter tube, movement of this tube
into contact with the tracheal wall may cause unintended closing of the valve. This
drawback may be avoided by constructing the valve as stated in claim 6, so that the
air may follow the long way round in case the short path between the two openings
is obstructed.
[0014] An embodiment of the respiration catheter of the invention is shown schematically
in the drawing partly in longitudinal section, fig. 1, partly in cross section, fig.
2, along the line II-II in fig. 1, and will be described more fully below with reference
to the drawing.
[0015] In the drawing, 10 is the end of a catheter tube intended for introduction into a
patient's trachea. Close to the obliquely cut end of the tube 11 is placed a sealing
cuff 12, which is made of a thin, preferably inelastic sheet material and encircles
the tube. Compressed air can be supplied to the cuff through a tubing system consisting
of two channels 13 and 14, which are provided in the wall of the catheter tube 10,
and which are both closed by a plug 15 and 16, respectively, at the end of the tube
10. One channel 13 can be connected through a tube 17 to a source of compressed air
(not shown) which delivers air with a substantially constant pressure, which may e.g.
be of the order of 20 to 30 cm H
2O. Between the end 11 of the catheter tube 10 and the adjoining end of the cuff 12,
each of the channels 13 and 14 are provided with a hole 19 and 20, respectively, opening
to the outside of the catheter tube, and these holes are covered by a rectangular
piece 21 of sheet, which is welded along the edges to the catheter tube 10 and thus
forms a valve which, controlled by the pressure conditions, can establish connection
between the two holes 19 and 20 and interrupt this connection. The channel 14 communicates
with the interior of the cuff 12 through another hole 22 positioned between the hole
20 and a plug 18. This channel additionally has a third hole 23 which is positioned
immediately beyond the end of the cuff 12 facing away from tube end 11 and such that
the plug 18 will be situated between the holes 22 and 23. This hole 23 opens to the
outer side of the catheter tube 10.
[0016] When the shown catheter is introduced into a patient's trachea, air is conducted
from the source of compressed air through the channel 13, the valve 19, 20, 21, and
the channel 14 and hole 22 to the cuff 12, which is thereby inflated and establishes
sealing engagement with the wall of the trachea. The pressure applied for this purpose
is so low that it cannot damage the mucuous membrane of the trachea. When, during
blowing of respiration air, the pressure at the end 11 of the catheter tube 10 exceeds
the pressure from the source of compressed air, the sheet 21 closes the holes 19 and
20 so that the air in the cuff cannot escape. The respiration pressure now acts on
the cuff side facing the lungs and increases the engagement pressure of the cuff.
This increased engagement pressure, which may be damaging if applied for a prolonged
period, is applied only during the short periods when the respiration pressure exceeds
the pressure from the source of compressed air.
[0017] Accordingly, the respiration catheter of the invention ensures effective sealing
against the tracheal wall under all circumstances, also in case of lungs of low compliance
requiring a high respiration pressure, and also ensures full perfusion of the tracheal
wall since the engagement pressure is below the value which may cause damage, except
for short moments.
[0018] The part of this channel positioned between the cuff 12 and the free end (not shown)
of the channel 14 may be used for sucking liquid from the space between the catheter
tube and the patient's trachea by connecting the free end with a suitable suction
means (not shown).
[0019] The invention is not restricted to the special embodiment shown and described above.
Instead of the rectangular sheet 21, a sheet ring may optionally be used, surrounding
the catheter tube and welded to the tube along the edges. This establishes two paths
between the holes 19 and 20, and if the short path is blocked, e.g. in that the catheter
tube engages the tracheal wall, air may pass the long way round the circumference
of the catheter tube.
[0020] Another possibility is to arrange the holes 19 and 20 in the inwardly facing side
of the channels 13 and 14 so that they open to the interior of the catheter tube,
and consequently place the sheet 21 on the inner side of the catheter tube.
[0021] The cut-off valve may also be constructed differently from what is described above
and may e.g. be formed by a sleeve or bladder of thin sheet material which connects
the two ends of the channels 13 and 14 with each other. Also the shape and position
of the channels may differ from what is shown and described.
1. A respiration catheter having a tube (10) intended for introduction into a patient's
trachea, encircled by a sealing cuff (12) which can be connected with a source of
compressed air through a separate tube (13, 14) accommodating a cut-off valve (19,
20, 21) which is controlled by the pressure of the respiration air, characterized in that the cut-off valve (19, 20, 21) is positioned in the vicinity of the catheter
tube end (11) facing the patient's lungs.
2. A respiration catheter according to claim 1, characterized in that the cut-off valve (19, 20, 21) is positioned on the sealing cuff side facing
the lungs.
3. A respiration catheter according to claim 1 or 2, characterized in that said separate tube is divided into two parts (13, 14), one (13) connected
with the source of compressed air, the other (14) communicating with the sealing cuff
(12), and that the two parts are interconnected through the cut-off valve (19, 20,
21).
4. A respiration catheter according to claim 3, characterized in that the tube part (14) connecting with the sealing cuff (12) has an extension
towards the air supply end of the catheter tube (10), and that said tube part, outside
and in the vicinity of the sealing cuff end facing the same way, has an opening (23)
to the outer side of the catheter tube and is closed between this opening and the
connection with the sealing cuff preferably by a plug (18) positioned in the tube
part.
5. A respiration catheter according to claim 3 or 4, characterized in that the cut-off valve is formed by a piece of sheet (21) which is so placed across
the openings (19, 20) in the two tube parts (13, 14) that, in unactivated state, it
allows connection between these two parts and interrupts this connection in activated
state.
6. A respiration catheter according to claim 5, characterized in that the sheet (21) is ring-shaped and surrounds the catheter tube (10).
7. A respiration catheter according to any of claims 1-5, characterized in that the cut-off valve (19, 20, 21) is positioned in the catheter tube (10).
1. Respirationskatheter mit einem Tubus (10), der zum Einführen in die Trachea eines
Patienten vorgesehen ist und von einer Dichtungsmanschette (12) umfaßt ist, die mit
einer Druckluftquelle über eine separate Leitung (13, 14) verbunden werden kann, die
ein Absperrventil (19, 20, 21) aufweist, das von dem Druck der Respirationsluft gesteuert
wird, dadurch gekennzeichnet, daß das Absperrventil (19, 20, 21) in der Nähe des Kathetertubusendes
(11), das den Lungen des Patienten zugewandt ist, angeordnet ist.
2. Respirationskatheter nach Anspruch 1, dadurch gekennzeichnet, daß das Absperrventil
(19, 20, 21) an der den Lungen zugewandten Seite der Dichtungsmanschette angeordnet
ist.
3. Respirationskatheter nach Anspruch 1 oder 2, dadurch gekennzeichnet, daß die separate
Leitung in zwei Teile (13, 14) unterteilt ist, wobei das eine Teil (13) mit der Druckluftquelle
verbunden ist und das andere Teil (14) mit der Dichtungsmanschette (12) kommuniziert,
und daß die beiden Teile durch das Absperrventil (19, 20, 21) miteinander verbunden
sind.
4. Respirationskatheter nach Anspruch 3, dadurch gekennzeichnet, daß das mit der Dichtungsmanschette
(12) verbundene Leitungsteil (14) eine Verlängerung in Richtung zum Luftversorgungsende
des Kathetertubus (10) aufweist, und daß dieses Leitungsteil außerhalb und in der
Nähe des in die gleiche Richtung weisenden Dichtungsmanschettenendes eine Öffnung
(23) zur Außenseite des Kathetertubus aufweist und zwischen dieser Öffnung und der
Verbindung mit der Dichtungsmanschette vorzugsweise durch einen Stopfen (18), der
in dem Leitungsteil angeordnet ist, verschlossen ist.
5. Respirationskatheter nach Anspruch 3 oder 4, dadurch gekennzeichnet, daß das Absperrventil
von einem Stück einer Folie (21) gebildet ist, die derart auf die Öffnungen (19, 20)
in den beiden Leitungsteilen (13, 14) gelegt ist, daß sie in nichtaktiviertem Zustand
eine Verbindung zwischen diesen zwei Teilen gestattet und in aktiviertem Zustand diese
Verbindung unterbricht.
6. Respirationskatheter nach Anspruch 5, dadurch gekennzeichnet, daß die Folie (21) ringförmig
ist und den Kathetertubus (10) umgibt.
7. Respirationskatheter nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, daß
das Absperrventil (19, 20, 21) in dem Kathetertubus (10) angeordnet ist.
1. Cathéter respiratoire possédant un tube (10) prévu pour être introduit dans la trachée
d'un patient, entouré d'un manchon d'étanchéité (12) qui peut être raccordé à une
source d'air comprimé par l'intermédiaire d'un tube distinct (13, 14) logeant une
vanne d'arrêt (19, 20, 21) qui est commandée par la pression de l'air respiré, caractérisé
en ce que la vanne d'arrêt (19, 20, 21) est placée à proximité de l'extrémité du tube
de cathéter (11) dirigée vers les poumons du patient.
2. Cathéter respiratoire selon la revendication 1, caractérisé en ce que la vanne d'arrêt
(19, 20, 21) est placée du côté du manchon d'étanchéité dirigé vers les poumons.
3. Cathéter respiratoire selon la revendication 1 ou 2, caractérisé en ce que ledit tube
distinct est divisé en deux parties (13, 14), l'une (13) étant raccordée à la source
d'air comprimé, l'autre (14) communiquant avec le manchon d'étanchéité (12), et en
ce que les deux parties sont raccordées l'une à l'autre par la vanne d'arrêt (19,
20, 21).
4. Cathéter respiratoire selon la revendication 3, caractérisé en ce que la partie de
tube (14) se raccordant au manchon d'étanchéité (12) possède une extension dirigée
vers l'extrémité d'alimentation en air du tube de cathéter (10), et en ce que ladite
partie de tube, à l'extérieur et à proximité de l'extrémité de manchon d'étanchéité
dirigée de la même manière, possède une ouverture (23) donnant sur le côté extérieur
du tube de cathéter, et est fermée entre cette ouverture et le raccordement au manchon
d'étanchéité, de préférence par un bouchon (18) placé dans la partie de tube.
5. Cathéter respiratoire selon la revendication 3 ou 4, caractérisé en ce que la vanne
d'arrêt est formée par une feuille (21) qui est placée de manière à recouvrir les
ouvertures (19, 20) dans les deux parties de tube (13, 14) de telle sorte que, à l'état
de repos, elle permet le raccordement de ces deux parties entre elles et interdit
ce raccordement à l'état actif.
6. Cathéter respiratoire selon la revendication 5, caractérisé en ce que la feuille (21)
a une forme annulaire et entoure le tube de cathéter (10).
7. Cathéter respiratoire selon l'une quelconque des revendications 1 à 5, caractérisé
en ce que la vanne d'arrêt (19, 20, 21) est placée dans le tube de cathéter (10).
